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Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints

Femoral Lengthening Might Impair Physical Function and Lead to Structural Changes in Adjacent Joints; 10 Patients With 27 to 34 Years Follow-up.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03966573
Enrollment
10
Registered
2019-05-29
Start date
2019-03-06
Completion date
2019-10-11
Last updated
2021-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leg Length Inequality, Leg; Lengthening, Osteoarthritis, Knee, Osteoarthritis of Hip, Quality of Life

Brief summary

This study evaluates function, quality of life and development of hip- and knee osteoarthritis minimum 15 years after unilateral femoral lengthening on people with idiopathic or post-traumatic anisomelia.

Detailed description

This study has a cross-sectional design, where patients that completed femoral lengthening more than 15 years ago and fulfills the inclusion criteria's are invited to participate. Patients will undergo radiographic imaging to evaluate hip- and knee arthritis, axis deviaton and leg length discrepancy. To evaluate quality of life, function and pain, the participants will complete the forms EQ-5D-5L, Knee osteoarthritis outcome score (KOOS) and International physical activity questionnaire (IPAQ). Bilateral active hip and knee range of motion will be measured with hand held goniometer, and the functional tests 30 seconds sit to stand, hop tests and stair test will be conducted.

Interventions

Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.

OTHEREvaluating function

Test function and physical capasity

OTHERForms

Forms for evaluating quality of life, pain, function

Sponsors

Sophies Minde Ortopedi
CollaboratorINDUSTRY
Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Patients with idiopathic or post traumatic leg length discrepancy who are lengthened with the callutasis method minimum 15 years ago

Exclusion criteria

* Patients that are lenghtened with innate pathology resulting in shortening of the limb, angle deviation and less musculature, for example congenital femoral deficiency or fibula hemimelia. * Patients with acquired leg length discrepancy who have had infection in knee or hip joint

Design outcomes

Primary

MeasureTime frameDescription
hip or knee osteoarthritisOne dayRadiographic imaging. Kellgren & Lawrence classification and joint space width will be measured
Lower extremity strengthone day30 seconds sit to stand test, measuring strength in lower extremities
Lower extremity functionone daySingle leg hop tests
Aerob capasityone dayStair test, 18 steps up and down three times
measure of health related quality of life with EQ-5D-5Lone dayparticipants report the extent of problems they have with endpoints 1-5, where 1 is no problems and 5 is not able to in the five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The questionnaire also contains a vertical analogue scale with the labelled endpoints 0-100 where 0 is the worst imaginable health state and 100 the best imaginable health state, giving a valuation of the participants own health state that can be used as a quantitative measure of health outcome based on the patients' own judgement
measure of function and pain with Knee Osteoarthritis Outcome Score (KOOS)one dayThe participant answer questions regarding pain, function, stiffness and quality of life regarding knee pain. Endpoints 0 - 4, where 0 indicate no problems and 4 indicate extreme problems
measuring physical activity level with International Physical Activity Questionnaire (IPAQ)one dayParticipants answer the amount of time being in vigorous activity, moderate activity, walking and sitting during the last 7 days. Answers are given in number of days in each of the activity categories, and time in hours and minutes on a regular day the actual week
Active range of motionone dayHand held goniometric measurement of active range of motion in hip and knee bilaterally

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026